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VVC Steps for PIs

  1. PI or Protocol Writer will call or email an RARC or WNPRC veterinarian to talk about the proposed protocol change that may be eligible for VVC as per policy UW-4132.
  2. The Veterinarian will determine if the change or changes to the protocol is allowed under the VVC Policy.
    1. If the Vet says the changes are not eligible, the Vet directs the PI/Writer to create and submit an amendment in ARROW describing the changes. The amendment is then reviewed by the ACUC via Designated Review or Meeting Review.
    2. If the Vet says YES changes are eligible for VVC, the Vet informs the PI/writer that the changes may begin immediately AND that the Vet will initiate a "VVC" submission in ARROW that the PI/Writer will have to review/edit and submit.
  3. The Vet creates a VVC submission and enters a synopsis of her/his discussion of the changes with the PI/Writer. The protocol now has a temporary suffix on the number of V##, and is in the State of "VVC Presubmission" pending further action by the Vet.
  4. The Vet will do one of two things:
    1. Make the changes that were discussed with the PI/Writer, and enter a "VVC Note" on the changed page(s) explaining the changes made to the PI/Writer.

      - OR -

      Only enter "VVC Notes" on specific pages directing the PI/Writer to make changes on those pages that were discussed.
  5. When done, the Vet saves and exits the VVC protocol.
  6. A RROW notifies the PI and Protocol Writers that the VVC submission is ready for them to check the Vet’s changes and notes and verify or edit changes.
  7. The PI/Writer logs into ARROW, locates the VVC submission, and clicks on the title to navigate to its Workspace. (The State of the protocol is "PI Review VVC.")
  8. To check the Vet’s work, it is most efficient to go to the "Quick Reviewer Notes for Study Team" on the Workspace. Click each "VVC" to go to the page in the protocol and check the Vet’s entries.
  9. The PI/Writer checks what the Vet changed, and/or follows the instructions in the Vet’s VVC Notes to make the requested changes.

    NOTE: If the PI/Writer is unsure how to respond, or disagrees with the Vet’s changes, they should contact the Vet outside of ARROW to discuss and resolve the discrepancies.

    NOTE: Only changes agreed upon by the consulting vet may be added during the VVC change process. If additional procedures or changes are added that do NOT qualify under the VVC policy, those will be removed and the PI will be directed to submit them via the normal ACUC change of protocol process.

  10. When the PI/Writer is ready to accept the changes in the VVC ARROW submission, the PI/Writer SAVES the protocol and EXITS the protocol, and is returned to the protocol Workspace.
  11. The PI/Writer clicks the activity button "Submit for VVC Review." This routes the submission out of the PI’s Inbox and back to the Vet.
  12. The Vet may have additional comments. If so, the Vet will send the submission back for another review by the PI/Writer. If not, the Vet will approve the submission as submitted.
  13. After the Vet clicks the activity button "VVC Approve," the PI is notified and the submission cycle is closed.

The changes are now part of the approved protocol, and the VVC event is documented in the "History" tab on the protocol Workspace.

The ACUCs review a log of VVC changes at each convened meeting.

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